ClinicalTrials.gov needs pregnancy eligibility fields — SkimNews
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- ClinicalTrials.gov lacks structured data on pregnancy and lactation eligibility despite hosting over 600,000 studies and drawing 3 million monthly visitors; the authors parsed 44,160 randomized drug trials and found 76% addressed pregnancy only in open-text fields — 0.8% explicitly permitted pregnant participants, 75% excluded them, and 24% left pregnancy unspecified.
- Fewer than 1% of drug development clinical trials enroll pregnant patients, a statistic that did not budge over 15 years of data and required the authors to use large language models plus hand-coded checks and phone calls to study coordinators to extract.
- ICH E21, a draft guideline from the International Council for Harmonisation, would shift drug development from presuming exclusion to recommending sponsors plan early to collect data in pregnant and lactating people; the FDA released it for public comment in July 2025 alongside regulators in Europe and Japan, with final adoption expected around early 2028.
- The National Academies of Sciences, Engineering, and Medicine's 2024 report "Advancing Clinical Research with Pregnant and Lactating Populations" noted it could not use ClinicalTrials.gov to measure the extent of pregnant and lactating trial participation and called for improved data sharing infrastructure.
- Trump administration officials have publicly criticized the lack of drug safety evidence in pregnancy around antidepressants and acetaminophen, adding political momentum to a push that the authors note already has rare bipartisan support.
- The 21st Century Cures Act established the Task Force on Research Specific to Pregnant Women and Lactating Women, which recommended a user-friendly website for listing registries and improving data infrastructure.
- Federal law since late 2007 has required registration of most Phase 2 to Phase 4 drug trials on ClinicalTrials.gov, meaning the missing pregnancy fields affect the overwhelming majority of U.S.-tracked drug research.
Why it matters: Adding structured pregnancy and lactation fields would let regulators track whether ICH E21, expected around early 2028, actually moves a needle that has stayed below 1% enrollment for 15 years. Clinicians and pregnant patients could immediately filter ClinicalTrials.gov's 600,000+ studies for eligible trials instead of parsing open-text criteria by hand or phone. The change is inexpensive and attracts bipartisan backing from a Trump administration criticizing pregnancy drug-safety gaps and the National Academies.
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